Combination of Xuesaitong and Aspirin Based on the Antiplatelet Effect and Gastrointestinal Injury: Study Protocol for a Randomized Controlled Noninferiority Trial.
Combination of Xuesaitong and Aspirin Based on the Antiplatelet Effect and Gastrointestinal Injury: Study Protocol for a Randomized Controlled Noninferiority Trial.
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DOI：
10.1155/2021/5552506
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发表时间：
2021
期刊：
影响因子：
--
通讯作者：
Hua GD
中科院分区：
文献类型：
--
作者：
Zhu BC;Xue CM;Lang R;Weng WL;Wang XJ;Lei ZZ;Zhang SS;Yang WH;Zhang WT;Hua GD
阿司匹林是预防和治疗冠心病的一线药物。但长期服用阿司匹林导致胃肠道黏膜损伤和出血，限制了规律用药。血塞通是以三七总皂苷（PNS）为主要活性成分的上市中药，具有显著抑制冠心病患者血小板聚集的作用。我们前期的临床前研究已经表明三七总皂苷可以减轻阿司匹林引起的胃肠道黏膜损伤。然而，需要进一步的临床研究来评估该组合的协同作用和减毒作用。 本试验是一项前瞻性计划、开放标签、平行分组、单中心临床试验。将符合条件的480例受试者按1：1：1的比例随机分为阿司匹林组、血塞通组和联合用药组。主要观察指标为血小板聚集率和钙卫蛋白活性的变化。次要结局包括PAC-1、P-选择素、P2 Y12、I-FABP活性和粪便潜血。讨论本研究结果有望为血塞通和阿司匹林在冠心病抗血小板和抗胃肠道损伤方面的协同作用提供高质量的方法学和报告证据。为临床合理联合用药提供了实验依据。试验注册。本试验于2020年8月22日在中国临床试验注册中心注册，ChiCTR 2000036311，http://www.chictr.org.cn/edit.aspx? pid=58798&htm=4.
Aspirin is the first-line medication for prevention and treatment of coronary heart disease (CHD). However, long-term use of aspirin resulting in gastrointestinal mucosal injury and bleeding limits the regularity of medication. Xuesaitong is a marketed Chinese medicine contained main active component in Panax notoginseng saponins (PNS), which can significantly inhibit platelet aggregation in patients with CHD. Our previous studies have already showed that PNS could reduce the gastrointestinal mucosal injury caused by aspirin in preclinical study. However, there is a need for further clinical studies to evaluate synergy and attenuation effect of the combination. This trial is a prospectively planned, open-labeled, parallel-grouped, single-centered clinical trial. A total of eligible 480 participants will be randomly allocated into three groups: aspirin group, Xuesaitong group, and drug combination group at a ratio of 1 : 1 : 1. The primary outcome is the change of platelet aggregation rate and calprotectin activity. Secondary outcomes include PAC-1, P-selectin, P2Y12, I-FABP activity, and fecal occult blood. Discussion. The results of the study are expected to provide evidence of high methodological and reporting quality on the synergy function of Xuesaitong and aspirin upon the antiplatelet and anti-gastrointestinal injury effect for CHD. It also provides an experimental basis for clinical rational drug combination therapy. Trial Registration. This trial was registered in the Chinese Clinical Trail Registry, ChiCTR2000036311, on 22 August 2020, http://www.chictr.org.cn/edit.aspx?pid=58798&htm=4.
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